Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Boehringer Ingelheim Roxane Inc to request your refund or repair — edit it as you like.
Subject: Recall D-1230-2014 — Boehringer Ingelheim Roxane Inc Boehringer Ingelheim Roxane Inc recalls Spiriva HandiHaler (tiotrop Hello, I own a Boehringer Ingelheim Roxane Inc recalls Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler that is covered by recall D-1230-2014 from Boehringer Ingelheim Roxane Inc. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.